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Silicone Urethral Catheter
EUDAMEDClass IIa (EU MDR)
Ref EC030620SDModel 3 Way Tiemann， 6.7mm(20Fr），5ml/10ml/15ml/20ml/30ml/50ml
Identity
- Trade Name
- Silicone Urethral Catheter EUDAMED
- Device Name
- Silicone Urethral Catheter EUDAMED
- Model / Reference
- 3 Way Tiemann， 6.7mm(20Fr），5ml/10ml/15ml/20ml/30ml/50ml EUDAMEDEC030620SD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941951021017 EUDAMED
- Basic UDI-DI
- B-06941951021017 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Urethral Catheter by Guangdong Ecan Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06941951021017 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangdong Ecan Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000020906
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED fc31b19f-1941-45ef-b57d-d90b2a7bd777 61 fields · synced Jun 18, 2026